|Publication number||US8157847 B2|
|Application number||US 12/755,569|
|Publication date||Apr 17, 2012|
|Priority date||Sep 11, 2000|
|Also published as||CA2421967A1, CN1455656A, EP1322244A2, EP1322244A4, US6358254, US8814867, US20070219555, US20100198277, US20120215312, WO2002021994A2, WO2002021994A3|
|Publication number||12755569, 755569, US 8157847 B2, US 8157847B2, US-B2-8157847, US8157847 B2, US8157847B2|
|Inventors||David Greg Anderson|
|Original Assignee||David Greg Anderson|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (57), Non-Patent Citations (8), Referenced by (3), Classifications (23), Legal Events (2)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a continuation of U.S. application Ser. No. 11/656,790, filed Jan. 22, 2007; which application is a continuation of U.S. application Ser. No. 10/102,525, filed Mar. 19, 2002 (now U.S. Pat. No. 7,166,107); which application is a continuation-in-part of U.S. application Ser. No. 09/659,180, filed Sep. 11, 2000 (now U.S. Pat. No. 6,358,254). The above identified related applications are incorporated herein by this reference.
The present invention relates generally to spinal surgery, and more particularly to a method and apparatus for expanding a spinal canal to relieve pressure on spinal nerves.
Spinal Stenosis, or narrowing of the spinal canal, inflicts millions of people with back and leg pain due to compression of spinal nerves. Severe spinal stenosis often leads to surgery in an effort to relieve compressed nerves and lessen back and leg pain. Spinal laminectomy is the traditional operation performed to treat spinal stenosis. In the spinal laminectomy, posterior aspects of the spinal column are removed to “un-roof” the spinal canal to relieve the pressure on the nerves. Specifically, a spinous process, lamina and portions of various facet joints are the posterior aspects of the spinal column surgically excised.
Although the spinal laminectomy is often successful in relieving pressure on the nerves of the spinal canal, several problems and disadvantages arise as a result of the laminectomy. First, the laminectomy removes important sites of back muscle attachment leading to back muscle dysfunction and pain. Second, the laminectomy exposes the nerve sac causing scar tissue to form around the nerves. Scar tissue may prevent normal motion of the nerves, leading to recurrent pain. Third, the laminectomy can destabilize the spine resulting in a forward slippage of one vertebra on another. Vertebral slippage can cause recurrent pain and deformity. Fourth, the laminectomy requires a large surgical exposure and significant blood loss, making the laminectomy dangerous for older patients. Finally, spinal stenosis can recur following the laminectomy, requiring risky revision surgery.
Laminectomy risks have led surgeons to seek an alternative for patients with severe spinal stenosis. Some surgeons choose to treat spinal stenosis with multiple laminotomies. Laminotomies involve removing bone and soft tissue from the posterior aspect of the spine making “windows” into the spinal canal over areas of nerve compression. Multiple laminotomies remove less tissue than the laminectomy, resulting in less scaring, vertebral instability and blood loss.
Multiple laminotomies, however, also suffer from problems and disadvantages. Laminotomies may not adequately relieve nerve compression and the pain may continue. Laminotomies are more difficult to correctly perform than the laminectomy. Laminotomies expose the nerves and may cause nerve scaring. Patients receiving multiple laminotomies also often have recurrent spinal stenosis requiring risky revision surgery.
For the foregoing reasons, there is a need for different and better methods for relieving the symptoms of spinal stenosis without the drawbacks of currently available techniques. A method is needed that expands the spinal canal, relieving pressure on the spinal nerves, while being simple, safe and permanent.
An initial invention was submitted by the present inventor entitled, “A Method and Implant for Expanding the Spinal Canal” (now U.S. Pat. No. 6,358,254). In the original application, a novel technique was disclosed to expand the spinal canal by lengthening the spinal pedicles on both sides of a vertebra resulting in decompression of compressed nerves while maintaining normal anatomic structures and muscle attachments. This disclosure relies on the same principle, namely that lengthening spinal pedicles can relieve the symptoms of spinal stenosis. This disclosure achieves expansion of the spinal canal by a percutaneous technique, thus eliminating the need for a larger incision.
The present invention provides a simple, safe, permanent, and minimally invasive method and apparatus for treating spinal stenosis by expanding the spinal canal area to provide additional space for the spinal nerves, relieving pressure on the spinal nerves.
Embodiments of the present invention will be seen variously:
to maintain the integrity of the spinal canal so that the function of normal tissues is not destroyed or significantly altered, which can occur with a laminectomy or laminotomy;
to avoid scarring around spinal nerves by avoiding an open exposure of the nerves;
to avoid an alternative procedure that can cause spinal instability, which occurs when one vertebra slips forward on another vertebra causing recurrent pain and deformity;
to decompress the spinal nerves with a quick, safe approach resulting in minimal blood loss;
to provide a permanent solution to spinal stenosis, where no tendency exists for recurrence; and to achieve decompression of the spinal canal through small percutaneous incisions, rather than a larger incision.
In one aspect of the present invention, a method for correcting spinal stenosis is introduced where a spinal canal is enlarged by cutting a vertebra through one or both pedicles, separating the vertebral cut and then stabilizing the cut. The vertebra can heal with the spinal canal expanded, thereby permanently creating more space for the spinal nerves, and relieving compression on the nerves.
In another aspect of the present invention, the method of expanding the spinal canal includes drilling a passage or hollow tunnel into at least a portion of one or both pedicles of a vertebra, making a pedicle cut (osteotomy) from within the passage through to the spinal canal and to the outside of the vertebra, distracting the osteotomy to expand the spinal canal, and then stabilizing the osteotomy. The osteotomy can be distracted by longitudinally lengthening the passage in the pedicle (about the cut) from within the passage. In this aspect, distraction occurs without (and not as a result of) impaction or insertion of a stent or implant into the pedicle cut. Or, in other aspects of the invention, distraction can occur by impaction or insertion of a stent or implant into the osteotomy.
In another aspect of the present invention, the method of expanding the spinal canal includes the following steps: first, a guide wire is inserted into a central portion of the vertebral pedicles on each side of a vertebra. This and other method steps can be accomplished with the assistance of x-rays, fluoroscopy, CAT scan or computer assisted image guidance technology, which are well known in the art of spinal surgery.
Second, the guide wire is used to direct the position of a cannulated drill (drill with a central barrel or passage to allow introduction over the guide wire) into each of pedicles to form a passage or hollow tunnel in the central portion of each pedicle. At the conclusion of this step the pedicles comprise a hollow column of bone having a central passage and thin, cylindrical, bony walls.
Next, the vertebral pedicles are cut circumferentially, forming an upper portion and a lower portion. A side-cutting instrument can be introduced into the central passage in each pedicle to perform the circumferential cut from within the passage. The side-cutting instrument has a cutting surface that projects radially outward so that the bony walls of each pedicle can be circumferentially cut. With both pedicles circumferentially cut, the vertebra is divided into an upper portion (including the spinous process, lamina, transverse process and articular processes) and a lower portion (including the vertebral body). The side-cutting instrument could include a rotating cutting burr or osteotome (chisel) as the cutting surface, both of which are well known in the art.
Next, each osteotomy (site of the circumferential bone cut) is distracted (widened or expanded). A specially designed implant can be used to distract the osteotomy by longitudinally lengthening the passage in the pedicle from within the pedicle. In one aspect of the present invention, the implant can include an outer sleeve and an inner bolt in communication with the outer sleeve. Movement of the inner bolt in relation to the outer sleeve longitudinally lengthens the implant to widen the osteotomy, thereby expanding the spinal canal.
In another aspect of the present invention, the implant can be threadably inserted into the central passage in each pedicle, and can include an outer sleeve divided into an upper and a lower portion; the division of the upper and lower portion being positioned at the site of the bone cut. The implant could also include an inner bolt capable of drawing the upper and lower portions of the outer sleeve apart, each part respectively attaching to the upper or lower portion of the pedicle by exterior threads which grip the bony walls of the pedicle.
The lower portion of the outer sleeve could also include expandable flanges which expand by the action of the inner bolt of the implant, resulting in the flanges being positioned between the drawn apart edges of the cut pedicle. The inner bolt of the implant could ultimately span across the separation between and engage the upper and lower portions of the outer sleeve, allowing secure fixation of the upper and lower portions of the outer sleeve by the action of the inner bolt.
Finally, the pedicle cut is secured in the elongated position, which can be accomplished by the action of the expandable flanges interposed between the cut surfaces of the pedicle and the inner bolt, the inner bolt securing the upper and lower portions of the outer sleeve by crossing the junction between the upper and lower portions of the outer sleeve.
The drawing apart of the upper and lower portions of the pedicles on each side of the pedicle cut cause expansion of the spinal canal, achieving pressure relief on the spinal nerves. The implants remains in the elongated pedicles, allowing bony healing of the pedicles, and thus creating permanent expansion of the spinal canal and preventing recurrence of the spinal stenosis.
In another aspect of the present invention, the expandable flanges include osteogenic material to assist in the healing of the osteotomy site, allowing the pedicles to heal in the elongated position, thereby permanently expanding the spinal canal.
In another aspect of the current invention, the implant includes a central barrel allowing introduction of the implant over a guide wire.
The present invention differs from current, unrelated techniques for treating spinal stenosis for at least the following reasons:
(1) Normal spine structures are not removed and thus normal muscle attachments are maintained;
(2) There is less chance of spinal instability;
(3) There is less manipulation of the spinal nerves;
(4) There is less scaring around the spinal nerves;
(5) Spinal decompression is more complete;
(6) The operation is quicker and safer with less blood loss;
(7) The expanded spinal canal is permanent, preventing recurrent spinal stenosis; and
(8) The procedure can be accomplished in a percutaneous fashion through very small incisions.
For the purpose of illustrating the invention, there is shown in the drawings a form which is presently preferred; it being understood, however, that this invention is not limited to the precise arrangements and instrumentalities shown.
Referring now to the drawings, where like numeral indicate like elements, there is shown in
The implant 16 includes an outer sleeve 17 and an inner bolt 18. The outer sleeve 17 is both externally and internally threaded. The inner bolt 18 is externally threaded to engage the internal threads of the outer sleeve 17. The outer sleeve 17 is divided into an upper portion 19 and a lower portion 20. The upper portion 19 and lower portion 20 of the outer sleeve 17 are divided at a separation point 25.
The lower portion 20 contains expandable flanges 21 which fit into the upper portion 19 of the outer sleeve 17 (as shown in
In operation, one method for expanding the spinal canal is summarized as follows: first, the guide wire 4 is placed into the central portion of the pedicle 2 of the vertebra 1 (
Next, the guide wire 4 is over drilled with a cannulated drill 6, leaving a passage (hollow tunnel) 7 through the central portion of the pedicle 2 but leaving the outer walls 23 intact (
Next, a circumferential cut (osteotomy) 11 is placed in the pedicle 2 (
Next, the pedicles 2 are elongated at the site of the circumferential cut 11 using the implant 16 (
The pre-elongated extended implant 16 is positioned within the passage 7 of the pedicle 2 to align the upper edge 28 of the circumferential cut 11 with the demarcation (separation) point 25 between the upper 19 and the lower 20 portions of the outer sleeve 17 (
The inner bolt 18 of the implant 16 is then threaded into the outer sleeve 17 causing the upper 19 and the lower 20 portions of the outer sleeve 17 to move apart. Because the exterior threads of the upper 19 and the lower 20 portions of the outer sleeve 17 have a good mechanical purchase of the bone of the upper 12 and the lower 13 portions of the pedicle 2, the pedicle is elongated a few millimeters (by a widening of the circumferential cut 11) as the upper 19 and the lower 20 portions of the outer sleeve 17 are drawn apart. The upper portion 19 of the outer sleeve 17 may need to be held motionless to assure that the upper 19 and the lower 20 portions of the outer sleeve 17 begin moving apart.
During rotation of the inner bolt 18, the distal end 26 of the inner bolt 18 pushes against the upper tip of the expandable flanges 21, causing the upper 19 and the lower portions 20 of the outer sleeve 17 to separate until the expandable flanges 21 clear the lower edge of the upper portion 19 of the outer sleeve 17. When the expandable flanges 21 are no longer contained within the upper portion 19 of the outer sleeve 17, the distal end 26 of the inner bolt 18 wedges itself under the reveal 27 (
An identical procedure is followed for the pedicles of both the right and the left side of the vertebra 1. To assist with pedicle healing at the circumferential cut 11, the expandable flanges 21 could be made of, or include, an osteogenic material to promote bone healing across the site of the pedicle 2 elongation.
These and other advantages of the present invention will be apparent to those skilled in the art from the foregoing specification. Accordingly, it will be recognized by those skilled in the art that changes or modifications may be made to the above-described embodiments without departing from the broad inventive concepts of the invention. It should therefore be understood that this invention is not limited to the particular embodiments described herein, but is intended to include all changes and modifications that are within the scope and spirit of the invention.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US2244683 *||Jun 11, 1938||Jun 10, 1941||Lloyd Fisher Samuel||Surgical saw|
|US2261230 *||Dec 16, 1938||Nov 4, 1941||Cox Wilbur J||Surgical apparatus|
|US3174387||Jun 4, 1962||Mar 23, 1965||Artur Fischer||Expansion bolt|
|US3896504||Oct 15, 1973||Jul 29, 1975||Fischer Artur||Hip joint prosthesis|
|US4013071||Nov 11, 1975||Mar 22, 1977||Lior Rosenberg||Fasteners particularly useful as orthopedic screws|
|US4716893||Dec 23, 1985||Jan 5, 1988||Artur Fischer||Bone fastener|
|US4917704||Jun 8, 1988||Apr 17, 1990||Sulzer Brothers Limited||Intervertebral prosthesis|
|US4955908||Jun 8, 1988||Sep 11, 1990||Sulzer Brothers Limited||Metallic intervertebral prosthesis|
|US5034011||Aug 9, 1990||Jul 23, 1991||Advanced Spine Fixation Systems Incorporated||Segmental instrumentation of the posterior spine|
|US5059193||Apr 19, 1990||Oct 22, 1991||Spine-Tech, Inc.||Expandable spinal implant and surgical method|
|US5108404||Aug 15, 1990||Apr 28, 1992||Arie Scholten||Surgical protocol for fixation of bone using inflatable device|
|US5176678||Mar 14, 1991||Jan 5, 1993||Tsou Paul M||Orthopaedic device with angularly adjustable anchor attachments to the vertebrae|
|US5258031||Dec 14, 1992||Nov 2, 1993||Danek Medical||Intervertebral disk arthroplasty|
|US5263803||May 7, 1993||Nov 23, 1993||Emhart Inc.||Anchor bolt|
|US5425772||Sep 20, 1993||Jun 20, 1995||Brantigan; John W.||Prosthetic implant for intervertebral spinal fusion|
|US5480440||Jul 7, 1993||Jan 2, 1996||Smith & Nephew Richards, Inc.||Open surgical technique for vertebral fixation with subcutaneous fixators positioned between the skin and the lumbar fascia of a patient|
|US5489210||May 13, 1994||Feb 6, 1996||Hanosh; Frederick N.||Expanding dental implant and method for its use|
|US5496322||Jul 22, 1994||Mar 5, 1996||Danek Medical Inc.||Method for subcutaneous suprafascial pedicular internal fixation|
|US5653762||Jun 7, 1995||Aug 5, 1997||Pisharodi; Madhavan||Method of stabilizing adjacent vertebrae with rotating, lockable, middle-expanded intervertebral disk stabilizer|
|US5653763||Mar 29, 1996||Aug 5, 1997||Fastenetix, L.L.C.||Intervertebral space shape conforming cage device|
|US5722977||Jan 24, 1996||Mar 3, 1998||Danek Medical, Inc.||Method and means for anterior lumbar exact cut with quadrilateral osteotome and precision guide/spacer|
|US5725527||Mar 27, 1996||Mar 10, 1998||Biedermann Motech Gmbh||Anchoring member|
|US5766251||Nov 15, 1996||Jun 16, 1998||Tomihisa Koshino||Wedge-shaped spacer for correction of deformed extremities|
|US5772663||Mar 17, 1997||Jun 30, 1998||Whiteside; Leo A.||Surgical device for banding bone with cable|
|US5827285||Dec 12, 1996||Oct 27, 1998||Bramlet; Dale G.||Multipiece interfragmentary fixation assembly|
|US5836948||Jan 2, 1997||Nov 17, 1998||Saint Francis Medical Technologies, Llc||Spine distraction implant and method|
|US5964761||Jul 15, 1997||Oct 12, 1999||Kambin; Parviz||Method and instruments for percutaneous arthroscopic disc removal, bone biopsy and fixation of vertebrae|
|US5980572||Apr 14, 1998||Nov 9, 1999||Asahi Kogaku Kogyo Kabushiki Kaisha||Artificial spines|
|US6008433||Apr 23, 1998||Dec 28, 1999||Stone; Kevin R.||Osteotomy wedge device, kit and methods for realignment of a varus angulated knee|
|US6009531||May 27, 1997||Dec 28, 1999||Ikos Systems, Inc.||Transition analysis and circuit resynthesis method and device for digital circuit modeling|
|US6018094||Sep 30, 1997||Jan 25, 2000||Biomedical Enterprises, Inc.||Implant and insert assembly for bone and uses thereof|
|US6077268||Apr 29, 1999||Jun 20, 2000||Sdgi Holdings, Inc.||Variable angle surgical cable crimp assembly and method|
|US6080157||Sep 11, 1996||Jun 27, 2000||Cg Surgical Limited||Device to stabilize the lamina|
|US6099531||Aug 20, 1998||Aug 8, 2000||Bonutti; Peter M.||Changing relationship between bones|
|US6129763||Sep 12, 1997||Oct 10, 2000||Chauvin; Jean-Luc||Expandable osteosynthesis cage|
|US6224599||Mar 2, 2000||May 1, 2001||Matthew G. Baynham||Viewable wedge distractor device|
|US6248106||Feb 25, 2000||Jun 19, 2001||Bret Ferree||Cross-coupled vertebral stabilizers|
|US6270501||Nov 8, 1999||Aug 7, 2001||The Regents Of The University Of Michigan||Surgical method and apparatus and cannulated scalpel for use therein|
|US6358254||Sep 11, 2000||Mar 19, 2002||D. Greg Anderson||Method and implant for expanding a spinal canal|
|US6402750||Apr 4, 2000||Jun 11, 2002||Spinlabs, Llc||Devices and methods for the treatment of spinal disorders|
|US6428256||Mar 14, 2001||Aug 6, 2002||Hilti Aktiengesellschaft||Attachment element for an anchor rod|
|US6610091||Oct 20, 2000||Aug 26, 2003||Archus Orthopedics Inc.||Facet arthroplasty devices and methods|
|US6635087||Aug 29, 2001||Oct 21, 2003||Christopher M. Angelucci||Laminoplasty implants and methods of use|
|US7166107||Mar 19, 2002||Jan 23, 2007||D. Greg Anderson||Percutaneous technique and implant for expanding the spinal canal|
|US20030028251||Jul 30, 2001||Feb 6, 2003||Mathews Hallett H.||Methods and devices for interbody spinal stabilization|
|US20030212400 *||Mar 11, 2003||Nov 13, 2003||Aesculap Ag & Co. Kg||Methods for treating spinal stenosis by pedicle distraction|
|US20060241774||Jun 7, 2006||Oct 26, 2006||David Attali||Apparatus for providing proper vertebral spacing|
|US20070219555||Jan 22, 2007||Sep 20, 2007||Anderson D G||Percutaneous technique and implant for expanding the spinal canal|
|US20080221623||May 21, 2008||Sep 11, 2008||Gooch Hubert L||Systems and Methods for the Medical Treatment of Structural Tissue|
|US20100168751||Nov 24, 2009||Jul 1, 2010||Anderson D Greg||Method, Implant & Instruments for Percutaneous Expansion of the Spinal Canal|
|US20100198277||Aug 5, 2010||Anderson D Greg||Percutaneous technique and implant for expanding the spinal canal|
|AU516581B2||Title not available|
|JP2000139970A||Title not available|
|JP2000152951A *||Title not available|
|JP2001079024A||Title not available|
|JPH114840A||Title not available|
|WO1997009940A1||Sep 11, 1996||Mar 20, 1997||C G Surgical Limited||A device to stabilise the lamina|
|1||First Examination in Australia Patent Application No. 2003220421 (now patented); Oct. 17, 2007 and Reply dated Nov. 12, 2008; 4 pages.|
|2||International Preliminary Report on Patentability. International Application No. PCT/US2003/008565; dated Mar. 2, 2010; 3 pages.|
|3||International Preliminary Report on Patentability; International Application No. PCT/US2009/065869; dated May 31, 2011; 9 pages.|
|4||International Search Report and Written Opinion; International Application No. PCT/US2009/065869; International Filing Date Nov. 25, 2009; 10 pages.|
|5||International Search Report; International Application No. PCT/US03/08565; International Filing Date Mar. 19, 2003; 3 pages.|
|6||Patent Abstracts of Japan, vol. 1999, No. 04, Apr. 30, 1999, and JP11004840, Jan. 12, 1999 (abstract).|
|7||Patent Abstracts of Japan, vol. 2000, No. 08, Oct. 6, 2000, and JP 2000139970, May 23, 2000 (abstract).|
|8||Patent Abstracts of Japan, vol. 2000; No. 09, Oct. 13, 2000, and JP2000152951, Jun. 6, 2000 (abstract).|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US8814867||Apr 17, 2012||Aug 26, 2014||Innovative Surgical Designs, Inc.||Percutaneous technique and implant for expanding the spinal canal|
|US9226756||May 14, 2013||Jan 5, 2016||DePuy Synthes Products, Inc.||Bone access instrument|
|WO2013059637A1||Oct 19, 2012||Apr 25, 2013||Innovative Surgical Designs, Inc.||Surgical implants for percutaneous lengthening of spinal pedicles to correct spinal stenosis|
|International Classification||A61B17/22, A61B17/86, A61F2/44, A61B17/70, A61B17/80, A61B17/56, A61B17/14, A61B17/16|
|Cooperative Classification||A61B17/14, A61B17/8004, A61B2017/22038, A61B17/7071, A61B17/1617, A61B17/8685, A61B17/1671, A61B17/1637, A61B17/1631|
|European Classification||A61B17/70Q, A61B17/86P, A61B17/16D2B, A61B17/14, A61B17/16S4|
|Feb 12, 2014||AS||Assignment|
Owner name: INNOVATIVE SURGICAL DESIGNS, INC., INDIANA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ANDERSON, D. GREG;REEL/FRAME:032251/0346
Effective date: 20110927
|Apr 17, 2015||FPAY||Fee payment|
Year of fee payment: 4